Events

Recall of HL 30 PERFUSION SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33350
  • Event Risk Class
    II
  • Event Initiated Date
    2013-02-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Maquet cardiopulmonary (mcp) has identified two potential issues with the hl30 device which will be addressed in a software upgrade. first in rare instances as a result of an accidental impact or "bump" to the pump head cover the unit may stop. this stoppage is intended to occur by design whenever the pump head cover is opened during operation. however if it occurs due to a rapid impact the unit may stop without an informational message explaining the reason for the stoppage. thus while it is apparent to the user that a stoppage occurred the user is unaware as to the reason. secondly maquet is addressing a software anomaly in the cardioplegia module whereby in a limited number of cases the unit slave pump did not engage after cardioplegia pause. maquet has eliminated the cause of this anomaly.

Device

HL 30 PERFUSION SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: HL 30 (Lot serial: 14031043); Model Catalog: HL 30 (Lot serial: 100033); Model Catalog: HL 30 (Lot serial: 100036); Model Catalog: HL 30 (Lot serial: 100038); Model Catalog: HL 30 (Lot serial: 14031007); Model Catalog: HL 30 (Lot serial: 14031010)
  • Product Description
    HL 30 PERFUSION SYSTEM
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC